| CTRI Number |
CTRI/2018/06/014503 [Registered on: 11/06/2018] Trial Registered Prospectively |
| Last Modified On: |
08/06/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study on Characteristics of cough and its impact on quality of sleep in children |
|
Scientific Title of Study
|
An observational study on characteristics of Cough and its impact on quality of sleep in children |
| Trial Acronym |
Cough in Children |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Ajitha Bala |
| Designation |
PG Scholar |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
National Institute of Siddha
Department of kuzhanthai maruthuvam
Tambaram sanatorium
Kancheepuram
Tamilnadu
National Institute of Siddha
Department of kuzhanthai maruthuvam
Tambaram sanatorium
Kancheepuram
Tamilnadu
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9789677235 |
| Fax |
04422381314 |
| Email |
kajithabala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenakshi Sundaram |
| Designation |
Associate professor |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
National Institute of Siddha
Department of kuzhanthai maruthuvam
Tambaram sanatorium
Kancheepuram
Tamilnadu
National Institute of Siddha
Department of kuzhanthai maruthuvam
Tambaram sanatorium
Kancheepuram
Tamilnadu
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meenakshi Sundaram |
| Designation |
Associate professor |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
National Institute of Siddha
Department of kuzhanthai maruthuvam
Tambaram sanatorium
Kancheepuram
Tamilnadu
National Institute of Siddha
Department of kuzhanthai maruthuvam
Tambaram sanatorium
Kancheepuram
Tamilnadu
Coimbatore
TAMIL NADU
600047
India |
| Phone |
9444214582 |
| Fax |
|
| Email |
mmssiddha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha
Tambaram sanatorium
Chennai |
|
|
Primary Sponsor
|
| Name |
Ayothidoss Pandithar Hospital |
| Address |
National Institute of Siddha
Tambaram sanatorium
Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Ajitha Bala |
National Institute Of Siddha |
Department of Kuzhandhai maruthuvam
Room no 9
Ayothidoss Pandithar Hospital
National Institute Of Siddha
Tambaram Sanatorium
chennai 47
Kancheepuram
TAMIL NADU |
9789677235
kajithabala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cough, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
NIS Patient in pediatric OPD
The patient with the complaint of cough
|
|
| ExclusionCriteria |
| Details |
Age group >12 years |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the characteristics of cough in children |
To evaluate the characteristics of cough in children |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the impact on Quality of sleep in children. |
zeroth day |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/06/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a Randomized ,cross sectional ,observational study to evaluate the Characteristics of cough and its impact on quality of sleep in children.Total sample size of the study is 200.The study will be conducted at Ayothidoss Pandithar hospital,National Institute of siddha ,Chennai.Outcome of the study will be assessed on the basis of Questionnaire. |